search
Back to results

Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy

Primary Purpose

Femoroacetabular Impingement, Hip Arthroscopy, Hip Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
Cortisone
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: candidates for hip arthroscopy for femoroacetabular impingement (FAI) ability to provide informed consent Exclusion Criteria: inability to provide informed consent; patients suffering from cancer or with poor general health conditions; patients suffering from coagulation diseases; positive history of tumor, infection, rheumatic or metabolic disease in the joint undergoing surgery; systemic inflammatory rheumatic diseases; pregnant or breastfeeding women; patients with proven hypersensitivity to collagen of bovine origin or vitamin C.

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cortisone (C)

Hydrolyzed Collagen Peptides

Arm Description

To improve the outcome of the arthroscopy during the procedure, cortisone is injected for anti-inflammatory purposes at the end of the surgical procedure.

The use is alternative to cortisone

Outcomes

Primary Outcome Measures

Hip disability & Osteoarthritis Outcome Score (HOOS) has five domains (pain, symptoms, activities of daily living, sports, recreational activities, quality of life): higher scores better hip function.
Investigate the preoperative symptoms and hip function
Visual Analogue Scale (VAS)
Investigate the preoperative hip pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Osteoarthtitis severity assessed with radiographic scoring system (Tönnis classification)
Investigate the degenerative changes to the hip. The score consists of three progressive degrees: 0 no osteoarthritis; form 1 to 3 increasing the degeneration.

Secondary Outcome Measures

Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative outcomes
Evaluation of the correlation between the presence of inflammatory molecules in the pre-operative synovial fluid and the post-operative HOOS in both groups and the presence of collagen degradation products in the urine in the pre-operative
Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative pain
Evaluation of the correlation between the presence of inflammatory molecules in the pre-operative synovial fluid and the post-operative pain score VAS in both groups and the presence of collagen degradation products in the urine in the pre-operative
Differences between the two study groups
Evaluate the differences between group I and group I+P in the clinical and functional outcome and in the use of analgesics

Full Information

First Posted
September 21, 2023
Last Updated
October 9, 2023
Sponsor
Istituto Ortopedico Rizzoli
Collaborators
Eleonora Olivotto
search

1. Study Identification

Unique Protocol Identification Number
NCT06082271
Brief Title
Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy
Official Title
Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
Collaborators
Eleonora Olivotto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hip Osteoarthritis (HOA) is the most common joint disorder and a major cause of disability in the adult population. Thus, the early diagnosis, prevention, and treatment of the early stages of the disease and of the pre-arthritic condition, in particular in adolescents and young adults, is crucial to reducing the incidence of end-stage HOA and the need for total hip replacement (THR). Evidence has mounted for a prominent etiologic role of femoroacetabular impingement (FAI) in the development of early HOA leading to the development of early cartilage and labral damage in the non-dysplastic hip. Therefore, the surgical treatment of FAI with mini-invasive arthroscopy is crucial. To improve the outcome after surgery, cortisone is routinely injected during the procedure for anti-inflammatory purposes. The aim of the study is to compare the use of cortisone (gold-standard) (C) to a new class III medical device based on hydrolysed Collagen Peptides PEP-52, Peptys (P) and to investigate potential associations among the preoperative symptoms and hip function, the outcomes after arthroscopic surgery and biomarkers in synovial fluids (SFs).
Detailed Description
Patients scheduled for hip arthroscopy for treatment of FAI and/or labral pathology will be enrolled. The two treatments, C or P, will be administrated to patients with random sampling. SFs samples, when available, are obtained by aspiration just prior to surgical intervention, collected and stored for biomarkers analysis. At the baseline, OA severity will be assessed with a radiographic scoring system (Tönnis classification). Physical examination and clinical assessment using the Hip disability & Osteoarthritis Outcome Score (HOOS) and VAS score for pain will be performed at the time of surgery and at 1-6 months of follow up. At the time of surgery, chondral (Outerbridge score) and labral pathology based on direct arthroscopic visualization will be also evaluated. The presence of inflammatory molecules at the baseline in the SFs will be also evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement, Hip Arthroscopy, Hip Osteoarthritis, Hydrolyzed Collagen Peptides

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients scheduled for hip arthroscopy for treatment of FAI and/or labral pathology were enrolled. The two treatments, cortisone (gold standard) or collagen Pepetids, were administrated to patients intraoperatively with random sampling
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cortisone (C)
Arm Type
Active Comparator
Arm Description
To improve the outcome of the arthroscopy during the procedure, cortisone is injected for anti-inflammatory purposes at the end of the surgical procedure.
Arm Title
Hydrolyzed Collagen Peptides
Arm Type
Experimental
Arm Description
The use is alternative to cortisone
Intervention Type
Device
Intervention Name(s)
Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
Intervention Description
Anti-inflammatory and regenerative effect, 5 mg/ml
Intervention Type
Drug
Intervention Name(s)
Cortisone
Intervention Description
DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml
Primary Outcome Measure Information:
Title
Hip disability & Osteoarthritis Outcome Score (HOOS) has five domains (pain, symptoms, activities of daily living, sports, recreational activities, quality of life): higher scores better hip function.
Description
Investigate the preoperative symptoms and hip function
Time Frame
Pre-operative; 1 and 6 months post-operative
Title
Visual Analogue Scale (VAS)
Description
Investigate the preoperative hip pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Time Frame
Pre-operative; 1 and 6 months post-operative
Title
Osteoarthtitis severity assessed with radiographic scoring system (Tönnis classification)
Description
Investigate the degenerative changes to the hip. The score consists of three progressive degrees: 0 no osteoarthritis; form 1 to 3 increasing the degeneration.
Time Frame
Pre-operative; 1 and 6 months post-operative
Secondary Outcome Measure Information:
Title
Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative outcomes
Description
Evaluation of the correlation between the presence of inflammatory molecules in the pre-operative synovial fluid and the post-operative HOOS in both groups and the presence of collagen degradation products in the urine in the pre-operative
Time Frame
Pre-operative; 1 and 6 months post-operative
Title
Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative pain
Description
Evaluation of the correlation between the presence of inflammatory molecules in the pre-operative synovial fluid and the post-operative pain score VAS in both groups and the presence of collagen degradation products in the urine in the pre-operative
Time Frame
Pre-operative; 1 and 6 months post-operative
Title
Differences between the two study groups
Description
Evaluate the differences between group I and group I+P in the clinical and functional outcome and in the use of analgesics
Time Frame
6 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: candidates for hip arthroscopy for femoroacetabular impingement (FAI) ability to provide informed consent Exclusion Criteria: inability to provide informed consent; patients suffering from cancer or with poor general health conditions; patients suffering from coagulation diseases; positive history of tumor, infection, rheumatic or metabolic disease in the joint undergoing surgery; systemic inflammatory rheumatic diseases; pregnant or breastfeeding women; patients with proven hypersensitivity to collagen of bovine origin or vitamin C.
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28235110
Citation
Nepple JJ, Clohisy JC; ANCHOR Study Group Members. Evolution of Femoroacetabular Impingement Treatment: The ANCHOR Experience. Am J Orthop (Belle Mead NJ). 2017 Jan/Feb;46(1):28-34.
Results Reference
background
PubMed Identifier
22730371
Citation
Agricola R, Heijboer MP, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Waarsing JH. Cam impingement causes osteoarthritis of the hip: a nationwide prospective cohort study (CHECK). Ann Rheum Dis. 2013 Jun;72(6):918-23. doi: 10.1136/annrheumdis-2012-201643. Epub 2012 Jun 23.
Results Reference
background
PubMed Identifier
21788902
Citation
Goldring MB, Otero M. Inflammation in osteoarthritis. Curr Opin Rheumatol. 2011 Sep;23(5):471-8. doi: 10.1097/BOR.0b013e328349c2b1.
Results Reference
background
PubMed Identifier
20924410
Citation
Sellam J, Berenbaum F. The role of synovitis in pathophysiology and clinical symptoms of osteoarthritis. Nat Rev Rheumatol. 2010 Nov;6(11):625-35. doi: 10.1038/nrrheum.2010.159. Epub 2010 Oct 5.
Results Reference
background
PubMed Identifier
22387238
Citation
Scanzello CR, Goldring SR. The role of synovitis in osteoarthritis pathogenesis. Bone. 2012 Aug;51(2):249-57. doi: 10.1016/j.bone.2012.02.012. Epub 2012 Feb 22.
Results Reference
background
PubMed Identifier
23194896
Citation
Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27.
Results Reference
background
PubMed Identifier
21098820
Citation
Nepple JJ, Carlisle JC, Nunley RM, Clohisy JC. Clinical and radiographic predictors of intra-articular hip disease in arthroscopy. Am J Sports Med. 2011 Feb;39(2):296-303. doi: 10.1177/0363546510384787. Epub 2010 Nov 23.
Results Reference
background
PubMed Identifier
21419955
Citation
Patel K, Wallace R, Busconi BD. Radiology. Clin Sports Med. 2011 Apr;30(2):239-83. doi: 10.1016/j.csm.2010.12.004.
Results Reference
background
PubMed Identifier
20886325
Citation
Dolan MM, Heyworth BE, Bedi A, Duke G, Kelly BT. CT reveals a high incidence of osseous abnormalities in hips with labral tears. Clin Orthop Relat Res. 2011 Mar;469(3):831-8. doi: 10.1007/s11999-010-1539-6. Epub 2010 Oct 1.
Results Reference
background
PubMed Identifier
21036688
Citation
Simpson J, Sadri H, Villar R. Hip arthroscopy technique and complications. Orthop Traumatol Surg Res. 2010 Dec;96(8 Suppl):S68-76. doi: 10.1016/j.otsr.2010.09.010. Epub 2010 Oct 30.
Results Reference
background
PubMed Identifier
32447428
Citation
Volpi P, Zini R, Erschbaumer F, Beggio M, Busilacchi A, Carimati G. Effectiveness of a novel hydrolyzed collagen formulation in treating patients with symptomatic knee osteoarthritis: a multicentric retrospective clinical study. Int Orthop. 2021 Feb;45(2):375-380. doi: 10.1007/s00264-020-04616-8. Epub 2020 May 23.
Results Reference
background
PubMed Identifier
24488223
Citation
Krych AJ, Griffith TB, Hudgens JL, Kuzma SA, Sierra RJ, Levy BA. Limited therapeutic benefits of intra-articular cortisone injection for patients with femoro-acetabular impingement and labral tear. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):750-5. doi: 10.1007/s00167-014-2862-3. Epub 2014 Feb 1.
Results Reference
background

Learn more about this trial

Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy

We'll reach out to this number within 24 hrs